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1.
INTRODUCTION AND OBJECTIVES: Most cardiac catheterizations are performed via femoral artery access, and hemostatic devices are commonly used. We evaluate the relationship between the strategy used for femoral arteriography and the use of VasoSeal-ES, and local vascular complications. PATIENTS AND METHOD: Prospective study of 540 consecutive catheterizations with systematic femoral artery and sheath angiography. VasoSeal-ES was used in 427 patients. Predictors of local vascular complications such as patient-related factors, anatomy and hemostasis were analyzed. Variables related to failure of the collagen plug were also studied. RESULTS: Punctures of the common femoral artery occurred in 35.9% of all patients (16% in the deep femoral artery and its ostium). Spasm was evident in 18% (ranging from 58.1% in the deep femoral artery to 5.2% in the common femoral artery). Puncture at the site of ramification was seen in 11.3%. Angiographically significant atheroma was seen in 17.8%. The femoral head was a valid landmark for the common femoral artery in only 63.9% of the pateints. Risk factors for local vascular complications were punctures of the common femoral artery, female sex and failure of VasoSeal-ES to achieve hemostasis (15.8% in the first two months of use, 5.2% in the last months of the study). Complications involving superficial and deep femoral arteries occurred in 6.7% and 1.2% of the patients, respectively, in contrast to 0.6% involving the common femoral artery. Variables related to collagen plug failure were patient-related factors, weight less than 55 kg, operator-related factors and the learning curve. CONCLUSIONS: Systematic femoral angiography provides data that aids the choice of the best hemostasis procedure to reduce local vascular complications. Punctures of the common femoral artery were more frequent than expected, and were associated with a higher complication rate. VasoSeal-ES is a safe and useful method of hemostasis, and its infrequent failures were associated with high complication rates that were substantially reduced with experience.  相似文献   

2.
Objectives: We studied the safety and efficacy of the Cardiva Boomerang Catalyst? vascular closure system in pediatric patients after cardiac catheterization with access in femoral and internal jugular vessels. Background: Recurrent catheterization and advances in pediatric interventions increase the need for easy hemostasis without a residual foreign body that may prevent re‐accessing the vessel. The Boomerang can be deployed in sheaths as small as 4Fr without residual foreign body, with minimal orientation needed, and few complications reported. Methods: In a two‐month period, all patients between 18 months and 21 years old catheterized with 4–8Fr sheaths less than 15 cm long were eligible for Boomerang placement. These were compared retrospectively with control patients with manual hemostasis. Anthropomorphic measurements, procedure type, activated clotting time, and sheath size as well as total times of cases, intubation, hemostasis, and extubation were compared between the two groups. Results: Forty‐six Boomerangs were deployed in 31 patients and compared with 40 patients with manual hemostasis. Boomerangs were deployed in femoral vessels and the internal jugular vein. Device success with hemostasis was achieved in 39 patients (85%). There were no significant differences in time to hemostasis or extubation between the two groups. No major complications or operator error occurred, including hematoma, transfusion, retroperitoneal bleed, infection, vessel occlusion, or need for surgery. Conclusions: The Boomerang is a safe and easy means of achieving hemostasis in the pediatric population, in femoral vessels as well as internal jugular veins. Its times to hemostasis and extubation were not significantly different from manual hold. © 2009 Wiley‐Liss, Inc.  相似文献   

3.
The aim of the present study was to assess the efficacy and safety of a thrombin-containing bandage for local hemostasis after femoral sheath removal in patients undergoing diagnostic cardiac catheterization. Forty-one patients undergoing diagnostic coronary angiography using a 6-F femoral sheath were included. The sheath was removed immediately after the procedure using the bandage according to a prespecified protocol. Mean compression time was 7.3+/-1.7 min and mean time from sheath removal to mobilization was 132+/-34 min. None of the patients suffered recurrent bleeding or any in-hospital and 7-day vascular complications. We conclude that in patients undergoing femoral-access diagnostic cardiac catheterization, the use of a hemostatic bandage containing thrombin was associated with short time to hemostasis with the ability for early patient mobilization without vascular complications.  相似文献   

4.
冠脉支架术后Perclose缝合与手工压迫止血的对比研究   总被引:6,自引:0,他引:6  
目的评价老年冠状动脉(以下称冠脉)支架术后Perclose缝合止血与手工压迫止血的优缺点,为老年冠脉支架术后处理穿刺血管提供参考。方法324例老年冠脉支架术后病人,165例Perclose缝合止血(缝合组),159例手工压迫止血(手工组)。比较止血时间、下肢制动时间、血管并发症、因卧床引起的不适发生率和止血后护理时间。结果两种止血方法同样安全有效。但是,缝合成功者止血时间、下肢制动时间和止血后护理时间明显较手工止血短,血管并发症及因卧床所致不适的发生率较手工止血低。缝合失败者上述时间明显延长,血管并发症及因卧床所致的不适程度增加。结论Perclose缝合止血的优点:(1)与手工止血同样安全有效;(2)止血、下肢制动和护理时间明显缩短,因卧床引起的不适和血管并发症发生率低。缺点:(1)费用昂贵;(2)一旦缝合失败,被迫在肝素化状态下压迫止血,导致血管并发症发生率增高,加重病人的经济和心理负担。  相似文献   

5.
Antegrade femoral artery access is commonly used for percutaneous transluminal revascularization of ipsilateral lower limbs in patients with critical limb ischemia. While hemostasis at the end of the procedure can be achieved by manual compression, this may lead to an increase in local vascular complications. Femoral artery closure devices, such as the Angioseal collagen plug and anchor device, have been approved and shown of benefit after retrograde femoral artery catheterization. To date, there are however no data on the use of such arteriotomy closure device after antegrade femoral access. We hereby report a case series of five patients in whom Angioseal was successfully used after antegrade femoral puncture and below-the-knee percutaneous transluminal angioplasty. In all cases the device enabled immediate and complete hemostasis without major complications, despite the intense antithrombotic regimen, including heparin, aspirin, and clopidogrel in all patients, as well as glycoprotein IIb/IIIa inhibitors (in two patients) and fibrinolytic therapy (in one).  相似文献   

6.
Aim of the present study was assessment of the StarClose Vascular Closure System - novel device for mechanical closure of femoral artery puncture site. We included in this study 29 patients in whom after procedure of endovascular treatment puncture site was closed with the given device. Control group comprised 34 patients in whom hemostasis was conducted by way of manual compression of puncture site according to standard technique. Femoral artery was clipped immediately after completion of the stenting procedure irrespective of the last result of activated partial thromboplastin time measurement. Success of the use of the StarClose was 100%. Activation of a patient was undertaken substantially earlier compared with the group of manual hemostasis. Sitting up in bed was performed in 2 hours after completion of hemostasis procedure compared with 16 hours in control group, walking within ward was started in 3.5 hours compared with 17 hours in control group ( < 0.0001 in both cases). Duration of the procedure of hemostasis was substantially smoller in the group of closing device compared with the group of manual hemostasis (1.7 and 23 min, respectively). With this no complications from the site of puncture were observed in the group of closing device. In the group of manual hemostasis one patient (2.9%) had hematoma nor requiring special treatment and in one more patient (2.9%) after violation of bed regimen minor bleeding occurred from puncture site (was eliminated by additional manual compression for 20 min). Total number of complications in the group of manual compression was 5.8%. Thus compared with traditional manual hemostasis. The use of StarClose clip device allows to activate patients after endovascular treatment substantially earlier.  相似文献   

7.
BACKGROUND: The optimal time for ambulating patients following femoral arterial puncture for percutaneous coronary intervention is unknown. This study was designed to test the hypothesis that reducing time to ambulation from 6 hours to 2 hours would not increase vascular complications. METHODS: In this randomized, controlled, single-center trial, patients were randomly assigned to receive either 2, 4 or 6 hours (control group) of bedrest after hemostasis was achieved at the femoral arterial puncture site. A total of 354 patients, enrolled from March 1997 to October 1998, participated in the study with 299 completing the full protocol. The primary endpoint was the incidence of vascular complications and any resulting interventions or outcomes including surgery, blood transfusion, prolonged length of stay or ultrasound compression. RESULTS: The 2 hour and 4 hour experimental groups were comprised of 99 patients each, while the 6 hour control group was comprised of 101 patients. There were no differences in vascular complications between the groups. A subgroup analysis of patients who received abciximab (n = 43) did not reveal any differences between groups. Only one patient developed a pseudoaneurysm (p = 0.36), requiring surgical repair and a prolonged length of stay. CONCLUSIONS: Patients undergoing femoral arterial puncture for coronary interventional procedures can safely ambulate 2 hours after hemostasis of the puncture site. Patients receiving abciximab as part of their coronary procedure may be able to ambulate as early as 2 hours following hemostasis.  相似文献   

8.
The procedures of left cardiac catheterization and revascularization by angioplasty are associated with a substantial risk of hemorrhagic complications. This risk increases clearly in patients with an intravascular stent who require early high doses of anticoagulant therapy. The first purpose of our study was to evaluate the effectiveness of a mechanical system of femoral hemostasis (Angio-Seala, Sherwood Davis & Geck, St. Louis, Missouri) deployed in a group of 411 consecutive patients (302 males, 109 females, mean age 59 +/- 15) who successfully underwent percutaneous angioplasty (PA) and application of an intravascular stent (378 coronary, 33 vascular). The arterial closure system consists of a small absorbable anchor and a collagen pad connected to a suture thread which, at the end of the procedure, is positioned by percutaneous introduction at the site of the femoral puncture. All the patients studied received long-term platelet anti-aggregant therapy (ticlopidine 500 mg/day and ASA 150 mg/day) for 3D4 days before and for one month after the procedure, and an anticoagulant regimen of heparin sodium administered via intravenous bolus (10,000 IU) during the procedure, followed by subcutaneous heparin calcium (12,500 IU/day) for 21 days. Thirteen patients were treated intravenously with 10 mg abciximab and seven received pre-procedure coumadin. The ACT when the hemostasis system was positioned was 355 +/- 43 seconds. Successful hemostasis was reached in more than 95% of the patients (394/411 pts., 95.86%). In 17 (4.14%) of the 411 patients studied, the system failed; nine (2.19%) of these were attributed by the operator to a failure of the positioning device procedure, and the remaining 8 (1.95%) were attributed to a malfunction of the system. Overall complications were observed in 23/411 (5.6%) of the patients (pts) studied; eighteen were minor non-surgical hemorrhagic complications (bleeding and/or hematoma) which occurred primarily in the first 4 hours. In 4 cases (1%) vascular surgery was necessary for femoral pseudoaneurysm repair (2 pts) and femoral hematoma (2 pts). One patient (0.24%) complained of severe claudication related to a severe stenosis in the femoral artery caused by a malpositioning of the anchor. This patient was successfully treated with balloon angioplasty and stenting of the femoral artery. The average time to early mobilization was 9 hours, and all the patients without complications were completely mobile within 12 hours after the procedure; 380/411 (92.46%) of the patients were discharged 18D24 hours after percutaneous angioplasty. The second purpose of our study was to compare data from 411 consecutive patients treated with the Angio-Seala device after coronary and vascular angioplasty and stenting (Angio-Seal group), to a group of 387 consecutive patients where the femoral arterial hemostasis was obtained using manual compression after coronary angioplasty and stenting (manual compression group). We found significant differences (p < 0.01) in the most important elements concerning general patient management after the interventional procedure, with excellent improvements using the Angio-Seal device, including: successful hemostasis (95.86% vs. 88.37%); reduction of non-surgical hematomas (1.22% vs. 4.65%); reduction of surgical hematomas (0.49% vs. 2.84%); mobilization time (9 +/- 3 hours vs. 19 +/- 8 hours); and discharge within 18D24 hours (92.46% vs. 0.00%).  相似文献   

9.
For the first time, a suture mediated closure device was used to obtain hemostasis after a catheterization procedure was performed via the brachial artery approach. Two successive catheterization procedures, using the right and left brachial arteries, were performed in a patient, contraindicated for a procedure through the femoral approach. In both cases the closures were successful and without complications. An aggressive anticoagulation regimen could safely be prescribed to this patient because of the percutaneous surgical achievement of hemostasis. This technique should provide interesting clinical benefits in selected patients undergoing catheterization via the brachial approach.  相似文献   

10.
目的 评价ProGlide血管缝合器预缝合技术(PCT)在经皮穿刺静-动脉模式体外膜肺氧合(VA-ECMO)血管通路撤机止血中应用的有效性及安全性。方法 研究为前瞻性、观察性研究,连续入选2019年3月~2020年6月期间在空军军医大学西京医院心脏内科接受经皮穿刺VA-ECMO治疗的患者。将成功撤机并利用PCT技术完成血管通路缝合的患者纳入研究,分别记录PCT技术在股动、静脉的成功率及住院期间穿刺部位相关并发症发生率。结果 研究共纳入37例接受经皮穿刺VA-ECMO治疗患者,排除5例患者(其中1例是未采用PCT技术,4例在ECMO撤机前死亡),最终纳入32例患者,结果发现PCT技术在股动脉的技术成功率为97%、股静脉成功率为100%。所有患者住院期间未发生主要血管并发症,次要血管并发症发生率为6%。结论 ProGlide预缝合技术在经皮穿刺VA-ECMO撤机时可以安全有效地实现股动、静脉的快速止血,且血管并发症发生率低。  相似文献   

11.
The purpose of this study was to determine if closure of the femoral artery access site using a percutaneous arterial suture device (Perclose, Menlo Park, CA) in patients undergoing coronary stenting can result in the same benefits as seen with radial artery access. A total of 218 consecutive patients underwent coronary stenting (109 femoral, 109 radial) by investigators experienced with each technique. The two groups were matched in terms of sex, age, clinical presentation (50% acute), number of vessels and lesions stented, and lesion morphology. The relative costs of the femoral and radial procedures were examined using a decision analytic model and sensitivity analysis. The suture device was not used in 20/109 patients (18%) for anatomic reasons and failed to obtain hemostasis in 9/89 patients (10%). One radial patient had an occluded radial artery postprocedure, but this was recanalized at follow-up a month later. Primary success, procedural complications, postprocedure length of stay, and the percentage of patients discharged the same day were the same in both groups. Because of the added time to deploy Perclose, total procedure time was significantly longer in the femoral group (57 +/- 22 min femoral vs. 44 +/- 22 min radial, P < 0.01). Access site complications occurred only in the femoral group. More patients were ambulatory the same day of the procedure in the radial group (95% radial vs. 56% femoral, P < 0.01). The cost of the radial approach was substantially less than the femoral approach because of lower supply costs and fewer access complications. The transradial approach is a dominant strategy for coronary stenting, offering better outcomes at lower cost. Cathet. Cardiovasc. Intervent. 49:150-156, 2000.  相似文献   

12.
Coronary catheter interventional procedures are associated with risk of access site complications. We report our experience with Angio-Seal™, an implantable hemostasis device, when used in the femoral artery after coronary angioplasty procedures. Sixty-eight patients were studied. Their average age was 63 years; 84% of the patients were male. All had 8 French access sheaths and received bolus heparin (mean dose 12,690 U). The arterial sheaths were removed an average of 455 min after the conclusion of the procedure, when the activated clotting time was 220 ± 94 sec (range 97–503 sec). The hemostasis device was successfully deployed in 63 patients (93%). The average time to achieve complete arterial hemostasis was 4.4 ± 8.9 min (range 0–45). Immediate, total hemostasis without requiring any form of external pressure was obtained in 37 of these patients (54%). The incidence of complications was as follows: significant bleeding occurred in 9 patients (13%); there were 2 hematomas (3%); there were no vascular or infectious complications. One device embolization occurred when the connecting suture broke and the intravascular anchor was lost; no clinical sequelae resulted, and manual hemostasis was successful. In four other patients, the device did not deploy and was removed entirely, followed by uneventful manual hemostasis. Follow-up for 2 months revealed no late sequelae in any patient, and complete absorption of the device was documented by ultrasound study in all cases. We conclude that this implantable device can achieve arterial hemostasis quickly and safely when used in anticoagulated patients after coronary interventional procedures. © 1996 Wiley-Liss, Inc.  相似文献   

13.
Objectives : To report the feasibility of a collagen‐mediated closure device using a modified Angio‐Seal closure technique for access site management following percutaneous balloon aortic valvuloplasty (BAV). Background : With the advent of percutaneous aortic valve replacement therapies, there has been a resurgence of interest in BAV procedures. Vascular complications, including bleeding, are a common source of morbidity post procedure as a result of the requirement for large bore femoral artery access. The use of vascular closure devices may reduce bleeding complications. Methods : We describe a new technique for vascular closure in this setting. At the conclusion of the valvuloplasty procedure, two 0.035″ wires are inserted through the femoral artery sheath. A conventional collagen‐mediated closure device (8F Angio‐Seal) is deployed over the first wire and along side the second wire. If immediate hemostasis is not achieved, a second device is loaded onto the second wire and deployed to achieve hemostasis. Results : Percutaneous BAV was performed in 21 patients. Hemostasis was successfully achieved in all patients with either a single 8F Angio‐Seal closure device (18 patients) or after placement of a second device (three patients). Conclusions : The modified “Double Wire” Angio‐Seal technique is a feasible method for hemostasis following percutaneous BAV. © 2009 Wiley‐Liss, Inc.  相似文献   

14.
Groin complications remain the most common complication of cardiac catheterization procedures. While the use of closure devices is increasing for arterial sheaths, venous sheaths tend to be removed and hemostasis achieved with manual compression. We report our experience using Perclose suture-mediated vascular closure device to achieve hemostasis and early mobility in patients who have had venous access as part of their procedure. There were a total of 42 patients (21 males; average age, 63.5 years) studied. The majority of the patients had 7 Fr sheaths (24), with access sites of sheaths up to 14 Fr being closed with this technique. Two patients developed complications at the access site: one patient requiring rehospitalization for intravenous antibiotics because of late access site infection, and one patient with deep venous thrombosis and pulmonary emboli. We conclude that the use of the Perclose suture-mediated closure device for closure of femoral venous access sites is feasible and should be considered especially in patients with larger venous sheaths and those at increased risk of groin complications.  相似文献   

15.

Background

The objective of this study is to evaluate the effectiveness and the safety of the FemoSeal mechanical closure system in order to obtain hemostasis of the puncture site following angioplasty procedures performed through femoral arterial approach.

Method

A single-centre prospective registry was conducted from November 2010 to April 2011, comparing the results of manual compression (n = 111 patients), hemostatic bandages compression (n = 43 patients) and FemoSeal mechanical closure (n = 100 patients). The end points evaluated were the following: successful hemostasis, major and minor complications right after the procedures and major and minor complications at 1 month follow-up. The patients’ feedback about their comfort was also collected right after the procedure and after one month.

Results

Successful hemostasis with FemoSeal was obtained in 93% of the patients (n = 93). Seven patients required additional slight manual compressions or compression bandages. The use of FemoSeal was not associated with any major complications, significantly reducing (P < 0.05) the number of complications compared to other compression techniques over the studied period. Only one minor complication was observed with FemoSeal (a 1.5-cm-hematoma, which reabsorbed spontaneously without any issue).

Conclusion

In our experience, the use of FemoSeal is effective in achieving hemostasis performed through femoral arterial approach up to 7F and is associated with a very low rate of complications.  相似文献   

16.
This study is intended to test whether the use of new 4 French (Fr) catheters can safely eliminate the need for supine bed rest and allow earlier ambulation while decreasing groin site complications and patient discomfort. Diagnostic left heart catheterization was performed using 4 Fr catheters via the femoral approach in 100 consecutive patients. After femoral sheath removal, the mean compression time with a mechanical compression device was 16.07 +/- 3.19 minutes. Mean manual compression time was 18.3 +/- 5.7 minutes. Ninety-eight patients were able to sit up 30 degrees immediately after hemostasis was achieved. The mean ambulation time was 2.18 +/- 0.71 hours. There were no major vascular complications. Four patients developed a small area (2.5-5 cm) of ecchymosis at the femoral arterial puncture site. The study demonstrated that upper body elevation and early ambulation are safe as soon as hemostasis is achieved after 4 Fr cardiac catheterization.  相似文献   

17.
The objective of this study was to assess the initial safety and feasibility of a novel suture-mediated device for closure of femoral access sites immediately after diagnostic or interventional cardiac catheterization. In a prospective study, 150 patients (mean age, 61.5 years; 109 male) underwent femoral access closure with a novel suture closure device (Superstitch, Sutura) immediately after diagnostic (n = 106) or interventional (n = 44) catheterization procedures, independently of the coagulation status. All patients were monitored for 24 hr after the procedure. The closure device was successfully deployed in 92% of patients. Immediate hemostasis was achieved in 77% of patients with no differences between patients undergoing diagnostic catheterization or coronary interventions (79% vs. 73%; P = 0.659). After 2 min of additional light manual compression, hemostasis was achieved in 92% of patients. There was one major complication requiring vascular surgery (0.7%). The novel suture closure device is a safe and effective device that allows for immediate closure of femoral puncture sites after both diagnostic and interventional procedures with a low rate of major complications.  相似文献   

18.
The use of topical hemostasis patches has grown rapidly despite a paucity of evidence supporting their clinical utility. We performed a randomized, controlled trial to assess the efficacy of a topical hemostasis patch as a means to accelerate vascular hemostasis following percutaneous intervention. One hundred fifty (150) patients undergoing coronary or peripheral intervention through a 6 Fr femoral arterial sheath were randomized to sheath removal with either: (1) manual pressure and adjunctive use of a patch incorporating a polysaccharide based procoagulant material (SafeSeal Patch, Possis Medical Inc.); or (2) conventional manual pressure alone. Sheaths were removed when the activated clotting time (ACT) fell to < or = 250 seconds. Patients ambulated 2 hours after hemostasis was achieved. Time to hemostasis (duration of compression required until cessation of bleeding following sheath removal) was significantly lower in the hemostasis patch arm (11.8 +/- 3.6 vs. 13.8 +/- 5.8 minutes; p = 0.02). Attainment of hemostasis in < 15 minutes was also more likely among patients randomized to the hemostasis patch rather than manual compression alone (odds ratio = 2.5; 95% confidence intervals 1.2, 5.1; p = 0.014). The median time to ambulation (total duration from the end of the interventional procedure to ambulation) was significantly reduced among patients in the hemostasis patch arm (2.8 vs. 3.8 hours; p = 0.03). Bleeding complications were uncommon and did not differ between the study arms. In conclusion, this trial supports the concept that the polysaccharide-based SafeSeal Patch enhances access site hemostasis following endovascular intervention.  相似文献   

19.
血管闭合装置在经皮冠状动脉成形术后的应用   总被引:1,自引:0,他引:1  
目的比较心血管病患者经皮冠状动脉成形术(PCI)后采用经皮血管闭合装置(per-close)止血与人工压迫止血的安全性和疗效。方法280例心血管病患者在行经皮冠状动脉成形术后,分为人工压迫止血组(145例)和per-close止血组(135例),观察2组止血时间、下床活动时间、术后血管并发症等。结果止血组与人工压迫组相比,止血时间与下床活动时间显著缩短,血管并发症明显减少。应用per-close的成功率达95%。结论此研究显示,PCI术后应用经皮血管闭合装置,是一个快速、有效的止血方法,缩短了止血与下床活动时间,并可减少穿刺点并发症发生率及患者不适感。  相似文献   

20.
目的:观察Perclose血管缝合器在经股动脉途径行室上速射频消融治疗中止血疗效比较。方法:199例经股动脉途径室上速射频消融治疗的患者被分为Perclose血管缝合组(Perclose组,98例)与人工按压组(101例),观察两组即刻成功率,止血时间,制动时间与术后并发症的发生率。结果:即刻止血成功率比较两组无统计学差异(98%比100%, P>0.05)。与人工按压组比较, Perclose组止血时间[(18.9±9.1) min比(2.7±0.7) min]和制动时间[(21.6±3.4) min比(6.3±2.4) min]明显缩短,并发症总发生率(16.8%比4.1%)明显降低(P<0.05, P<0.01)。两组并发症发生的具体情况:迷走反射 Perclose组明显低于人工按压组(0比7.9%, P<0.05),其他并发症两组无统计学差异(P均>0.05)结论:Perclose血管缝合器止血时间、制动时间短,并发症少,可作为经股动脉途径室上速射频消融治疗后股动脉止血的优先选择。  相似文献   

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